Ignite Creation Date:
2024-05-05 @ 10:17 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01077934
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2010-02-24
Brief Title:
Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
Sponsor:
JM Shuler
Organization:
JM Shuler
Study Overview
Official Title:
Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy NIRS in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time We hypothesize that this technology combined with vital signs intracompartmental pressures and clinical examinations will be useful in diagnosing acute compartment syndrome ACS monitoring patients at risk for ACS and evaluating the adequacy of fasciotomy in patients treated for ACS
Detailed Description:
Acute compartment syndrome ACS is associated with lower leg trauma in up to 20 of high energy injuries ACS occurs when the pressure due to swelling exceeds the perfusion pressure thereby cutting off blood flow to the leg If untreated the results can be catastrophic with an insensate contracted leg Moreover there is a high risk of subsequent infection and even amputation The treatment for ACS a four compartment fasciotomy is aimed at releasing the pressure through two incisions from roughly the knee to the ankle Often due to wound expansion the incisions require multiple debridements and skin grafting to close With fasciotomies fractures are converted from closed to open injuries When left open for many days the risk of infection and complications such as nonunion increase significantly
The only accepted objective method for diagnosis of ACS is to measure the pressure inside the leg compartments by using a large gauge needle hooked to a pressure monitor However these readings can be erroneous if not performed correctly As such ACS continues to be a clinical diagnosis which is made based on the surgeons experience and their interpretation of the character of the injury high-energy motorcycle crash vs low-energy a twisted ankle Clinicians are left to attempt to interpret physical exam findings and readings from pressure monitors Most importantly ACS is not an event but a process that can manifest at multiple points after injury The most accurate and effective method for diagnosing and appropriately treating ACS is serial examination over a course of hours to days
With this study we hope to evaluate the NIRS device which is non-invasive as diagnostic tool in the evaluation of acute compartment syndrome We plan to evaluate all patients by the gold standard in diagnosing acute compartment syndrome while simultaneously evaluating the patient with the NIRS device This will allow us to determine if the NIRS device can accurately and reliably predict the development of acute compartment syndrome in a non-invasive longitudinal manner
Access to a precise reliable and noninvasive method for early diagnosis of ACS would be a landmark achievement in orthopaedic and emergency medicine
The only accepted objective method for diagnosis of ACS is to measure the pressure inside the leg compartments by using a large gauge needle hooked to a pressure monitor However these readings can be erroneous if not performed correctly As such ACS continues to be a clinical diagnosis which is made based on the surgeons experience and their interpretation of the character of the injury high-energy motorcycle crash vs low-energy a twisted ankle Clinicians are left to attempt to interpret physical exam findings and readings from pressure monitors Most importantly ACS is not an event but a process that can manifest at multiple points after injury The most accurate and effective method for diagnosing and appropriately treating ACS is serial examination over a course of hours to days
With this study we hope to evaluate the NIRS device which is non-invasive as diagnostic tool in the evaluation of acute compartment syndrome We plan to evaluate all patients by the gold standard in diagnosing acute compartment syndrome while simultaneously evaluating the patient with the NIRS device This will allow us to determine if the NIRS device can accurately and reliably predict the development of acute compartment syndrome in a non-invasive longitudinal manner
Access to a precise reliable and noninvasive method for early diagnosis of ACS would be a landmark achievement in orthopaedic and emergency medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None